Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

This study has been completed.
Sponsor:
Collaborator:
Winthrop University Hospital
Information provided by (Responsible Party):
Sean Tutton, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00765258
First received: September 30, 2008
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

To examine, through retrospective and prospective chart review, the difference in pain and mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain scale and Roland Morris Disability Questionnaire (RMDQ).

CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.


Condition
Sacro-iliac Insufficiency Fractures

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Reduction of pain and improved mobility in patients post percutaneous sacroplasty effectively assessed using the VAS pain scale and RMDQ both pre and post procedure. [ Time Frame: 2008-2012 ] [ Designated as safety issue: Yes ]
    The average pre-treatment VAS score was significantly improved after sacroplasty in patients with sacral insufficiency fractures.


Enrollment: 14
Study Start Date: January 2008
Study Completion Date: February 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of the study is to report the use of CT fluoroscopy guidance during the performance of percutaneous sacroplasty. In addition, clinical results will be reported with the Roland Morris Disability Questionnaire(RMDQ)pre and post procedure, demonstrating the utility of the RMDQ in assessing improvement in patients pain, mobility and ability to perform activities of daily living.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient's with pain and decreased mobility as a result of sacro-iliac insufficiency fracture(s).

Criteria

Inclusion Criteria:

  • greater than 18 years of age and treated with or about to be treated with percutaneous CT fluoro-guided sacroplasty, regardless of gender or ethnicity.

Exclusion Criteria:

  • less than 18 years old
  • pregnancy
  • inability to complete forms and surveys
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765258

Locations
United States, Wisconsin
Medical College of Wisconsin / Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Winthrop University Hospital
Investigators
Principal Investigator: Sean M Tutton, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Sean Tutton, MD, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00765258     History of Changes
Other Study ID Numbers: PRO00008209
Study First Received: September 30, 2008
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Stress
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014